CLINICAL TRIALS PROFILE FOR LONSURF

505(b)(2) Clinical Trials for Lonsurf

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT07235293 ↗	A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.	NOT_YET_RECRUITING	Novotech (Australia) Pty Limited	PHASE2	2025-11-15	This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
New Combination	NCT07235293 ↗	A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.	NOT_YET_RECRUITING	Kahr Bio Australia Pty Ltd	PHASE2	2025-11-15	This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.

All Clinical Trials for Lonsurf

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Astex Pharmaceuticals, Inc.	Phase 1/Phase 2	2013-10-23	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Van Andel Research Institute	Phase 1/Phase 2	2013-10-23	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Sidney Kimmel Comprehensive Cancer Center	Phase 1/Phase 2	2013-10-23	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 1/Phase 2	2013-10-23	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).

Clinical Trial Conditions for Lonsurf

Condition Name

Condition Name for Lonsurf
Intervention	Trials
Metastatic Colorectal Cancer	9
Stage IVA Colorectal Cancer AJCC v8	6
Colorectal Cancer	6
Stage IVC Colorectal Cancer AJCC v8	6

Condition MeSH

Condition MeSH for Lonsurf
Intervention	Trials
Colorectal Neoplasms	33
Adenocarcinoma	20
Carcinoma	10
Colonic Neoplasms	7

Clinical Trial Locations for Lonsurf

Trials by Country

Trials by Country for Lonsurf
Location	Trials
United States	133
Australia	18
Japan	17
Taiwan	8
France	7

Trials by US State

Trials by US State for Lonsurf
Location	Trials
Florida	13
California	13
Texas	11
Minnesota	9
Arizona	9

Clinical Trial Progress for Lonsurf

Clinical Trial Phase

Clinical Trial Phase for Lonsurf
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	2
PHASE1	1

Clinical Trial Status

Clinical Trial Status for Lonsurf
Clinical Trial Phase	Trials
Recruiting	30
Not yet recruiting	10
Active, not recruiting	10

Clinical Trial Sponsors for Lonsurf

Sponsor Name

Sponsor Name for Lonsurf
Sponsor	Trials
National Cancer Institute (NCI)	14
Taiho Oncology, Inc.	8
Academic and Community Cancer Research United	5

Sponsor Type

Sponsor Type for Lonsurf
Sponsor	Trials
Other	70
Industry	36
NIH	14

Clinical Trials Update, Market Analysis, and Projection for Lonsurf (TAS-102)

Last updated: October 28, 2025

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Introduction

Lonsurf (generic name: TAS-102) is an oral combination chemotherapeutic agent comprising trifluridine and tipiracil hydrochloride. Approved by the US Food and Drug Administration (FDA) in 2015 for metastatic colorectal cancer (mCRC), Lonsurf has gained significance as a treatment option post-failure of standard therapies. Its unique mechanism—combining a nucleoside metabolic inhibitor with a thymidine phosphorylase inhibitor—distinguishes it within the colorectal cancer therapy landscape.

This report provides a comprehensive update on Lonsurf’s ongoing and completed clinical trials, evaluates its current market position, and projects future growth trajectories based on recent developments and market dynamics.

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Clinical Trials Update

Recent Clinical Development Highlights

Lonsurf’s clinical journey remains active, leveraging both Phase III trials and investigator-led studies to expand its therapeutic indications and optimize patient outcomes.

1. RELAY Trial (NCT02997228):
   A pivotal phase III trial evaluating Lonsurf in the adjuvant setting for early-stage colorectal cancer is underway, aiming to establish its efficacy outside metastatic contexts. While initial results are pending, the trial signals an expanding scope.

2. Combination Therapy Trials:
   Multiple ongoing studies are probing Lonsurf synergized with immune checkpoint inhibitors like pembrolizumab and nivolumab. These combinations target resistant tumors with immunotherapy agents, seeking to enhance response rates. For instance, NCT04640052 tests Lonsurf with pembrolizumab in microsatellite stable (MSS) colorectal cancer—a domain with limited current options.

3. Third-Line and Beyond:
   Continued investigations solidify Lonsurf’s role in late-line therapy. Real-world evidence from retrospective analyses (published in recent oncology journals) demonstrates improved overall survival (OS) and progression-free survival (PFS) in patients receiving Lonsurf after prior treatments.

Regulatory and Market Approvals

Aside from FDA approval, Lonsurf holds approvals in numerous markets including Europe, Japan, and South Korea. The European Medicines Agency (EMA) approved it in 2017 for similar indications, with national agencies extending indications based on additional data.

Emerging Indications

Recent Phase II trials explore Lonsurf’s efficacy in gastric and pancreatic cancers, but results remain preliminary. These efforts reflect a trend to leverage its mechanism in other gastrointestinal malignancies, with some early signals of activity warranting further validation.

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Market Analysis

Current Market Landscape

The colorectal cancer therapeutics market is highly competitive, with agents like cetuximab, bevacizumab, and regorafenib occupying the second-line space. Lonsurf maintains a strong position due to its oral administration, manageable safety profile, and evidence of survival benefit.

According to IQVIA data, Lonsurf generated approximately $560 million USD in global sales in 2022, with the US accounting for the majority share. The drug’s sales have steadily increased, driven by an aging population, rising colorectal cancer incidence, and expanding indications.

Key Market Drivers

• Growing Incidence of Colorectal Cancer:
  Global colorectal cancer incidence is predicted to rise at a CAGR of about 3.2% over the next decade, fueling demand for effective therapies [1].

• Shift Toward Oral Chemotherapy:
  Patients and clinicians favor oral agents for convenience and quality of life. Lonsurf’s oral formulation grants it a competitive edge.

• Post-Failure Treatment Niche:
  As a third-line therapy, Lonsurf fulfills an unmet need for patients refractory to first- and second-line treatments, maintaining robust demand.

Market Challenges

• Competitive Landscape:
  Regorafenib, trifluridine/tipiracil (Lonsurf), and TAS-102’s emerging biosimilars pose competitive pressures. Bayer’s tendency to focus on niche indications may impact Lonsurf’s market penetration.

• Pricing and Reimbursement:
  High costs and variable reimbursement policies across regions could constrain adoption, especially in cost-sensitive markets.

• Safety Profile Concerns:
  Myelosuppression and gastrointestinal side effects require management, occasionally limiting therapy adherence.

Future Market Projections

The global colorectal cancer drug market is projected to hit $10.6 billion USD by 2030, expanding at a CAGR of 5%, with TAS-102 expected to sustain part of this growth [2].

Lonsurf’s share is anticipated to increase, especially if ongoing trials demonstrate new indications. Market analysts estimate a compounded annual growth rate (CAGR) of 4-6% over the next five years for Lonsurf, driven by sales of existing indications, pipeline pipeline expansion, and geographic market penetration.

Pipeline Opportunities and Strategic Outlook

• Potential Expansion into Adjuvant and Neoadjuvant Settings:
  Successful trials could unlock earlier usage, substantially increasing the patient population size.

• Combination Therapies:
  Synergistic regimens with immunotherapies or targeted agents could elevate efficacy, broaden indications, and extend market relevance.

• Emerging Markets:
  Growing healthcare infrastructure in Asia-Pacific and Latin America offers expansion avenues, contingent on pricing strategies.

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Projection Summary

Aspect	Short-Term (1-3 years)	Mid to Long-Term (3-10 years)
Sales Growth	Steady increase, driven by existing use	Accelerated through new indications and combination therapies
Market Penetration	Stabilizing in core markets	Expanding into emerging regions
Indication Expansion	Pending trial results for early-stage and non-colorectal cancers	Potential approval for adjuvant and combination regimens
Competitive Position	Maintains solid niche but vulnerable to biosimilars	Sustained through pipeline and partnership strategies
Regulatory Landscape	Continued approvals, potential label expansions	Increased approvals for combined or expanded indications

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Key Takeaways

• Clinical Trials Progress:
  Lonsurf remains a pivotal agent in late-line colorectal cancer treatment, with active trials exploring combination therapies and new indications. Pending results may further redefine its clinical utility.

• Market Position:
  With global sales surpassing half a billion dollars, Lonsurf has established itself as a valuable asset in colorectal cancer management, supported by favorable safety profile and oral administration.

• Growth Opportunities:
  Pipeline developments targeting earlier treatment lines, combination regimens with immunotherapies, and expansion into non-colorectal gastrointestinal cancers represent significant future growth drivers.

• Market Challenges:
  Pricing pressures, competitive biosimilars, and safety considerations necessitate strategic positioning, including value-based care negotiations and stewardship.

• Strategic Outlook:
  By leveraging ongoing research and expanding geographic coverage, Lonsurf is poised to sustain moderate growth, particularly if emerging indications validate further utility.

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FAQs

1. What are the primary indications for Lonsurf currently?
Lonsurf is approved for metastatic colorectal cancer, particularly in patients who have failed at least two prior chemotherapy regimens, including fluoropyrimidines, oxaliplatin, and irinotecan.

2. Are there ongoing clinical trials expanding Lonsurf’s use?
Yes. Several trials are evaluating Lonsurf in adjuvant settings, early-stage disease, and in combination with immunotherapies for resistant colorectal and other gastrointestinal cancers.

3. How does Lonsurf compare to other chemotherapeutic agents?
Lonsurf’s oral formulation, survival benefit in refractory cases, and manageable side effect profile distinguish it from intravenous chemotherapies and biologics. However, its choice depends on patient-specific factors and prior therapy history.

4. What are the main safety considerations associated with Lonsurf?
Common adverse events include myelosuppression, fatigue, nausea, and diarrhea. Regular monitoring of blood counts is necessary to mitigate risks.

5. What is the outlook for Lonsurf’s market growth?
Projected to grow at an annual rate of approximately 4-6% over the next five years, driven by pipeline development, expanding indications, and increasing global colorectal cancer incidence.

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References

[1] Globocan 2020. "Colorectal Cancer." International Agency for Research on Cancer.
[2] MarketWatch. “Global Colorectal Cancer Drugs Market Analysis, 2020-2030.”